Human Subjects Review Criteria

The NIH defines “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.”

Capstone Projects are subject to Human Subjects Review approval if:

Information from individuals is collected via surveys, administrative data, observation, or other means.

The results of the study will be disseminated via the media or other means beyond the client organization and the Policy Studies community (faculty, students, and others participating in the course or in presentations of degree projects).

Capstone Projects are NOT subject to HSR approval if:

No information about individuals is collected

The project is being conducted ONLY for distribution to a client organization (and the individuals studied are employees, clients, or other members of that organization)

The work will not be disseminated beyond the client organization and the Policy Studies community

You are responsible for checking with your faculty advisor or course instructor prior to beginning collection of any data.

The faculty advisor or course instructor is responsible for guiding your work in a timely way and checking with HSR if there are questions on applicability of this process.

If, in the course of a project, dissemination of the research becomes likely, you and your advisor are both responsible for immediately beginning the HSR application process.

If you choose to submit your project for Human Subjects Review screening, the following information will be relevant.

Information relevant to Human Subjects Review can change at any time; therefore, please consult the Human Subjects web site to ensure you have the latest information and/or documents. Review times vary; allow a minimum of eight weeks for review and be prepared to offer additional information. Study procedures may not begin until notice of approval has been received from Human Subjects Division.

Initial Screening

Submit your proposal to your Capstone Advisor, who will make an initial review and a recommendation as to the appropriate review procedure. Once you have determined the correct category of review (see the three available categories below), you are responsible for seeking the appropriate signatures. You should submit your own HSR application via campus mail, and submit a copy of the signature page to the IAS Graduate Office.

Exempt Review

In this category, you are required to complete the “Certificate of Exemption” form and submit it with all appropriate copies and attachments (proposal, protocol, consent forms or request for waiver of consent). Study procedures may not begin until notice of approval has been received from Human Subjects Division. If the application is complete, and meets requirements for exempt review the process should take 2-3 weeks, but often the reviewers will require additional information, which could cause delays.

Please note that the cover sheet of the Human Subjects Application (Form 13-11) and the Certification of Exemption form requires the signature of your instructor as well as the signature of the IAS Associate Director for Graduate Education, who signs as "Dean, Director, or Chair."

Institutional Review – Minimal Risk

Please submit 3 copies of Form 13-11 for research projects that require "minimal risk" review. Examples of procedures that qualify for "minimal risk" review are: 1) interviewing children for the sole purpose of research, 2) using secondary data that are linked to the subjects' identities, or 3) conducting focus groups. The content of questionnaires, surveys, or interviews should not be sensitive (content should not stigmatize the subjects if the data found an unintended audience).

Institutional Review – Full Review

Please submit 9 copies of Form 13-11 for research projects that require a full committee review. Examples that need full committee review are: 1) conducting interviews or surveys linked to the subjects' identities that could potentially stigmatize the subjects if the data found an unintended audience, 2) collecting primary data on vulnerable subject populations, like prisoners or people who are cognitively impaired, or 3) collecting primary data that are sensitive and are linked to the subjects identities, such as alcohol abuse, sexual practices, or any illegal activity.

Please attach all study instruments to the Human Subjects application (for example, questionnaires, surveys, or interview protocols). In addition, please attach the appropriate consent forms and assent forms. You should also attach a letter of cooperation from each agency or institution where you will conduct study procedures (or state in section VII.D.5. that the letter of cooperation is pending).

Please note that the cover sheet of the Human Subjects Application (Form 13-11) requires the signature of your advisor as well as the signature of the IAS Associate Director for Graduate Education.